MULTI-SYMPTOM COLD AND FLU-KIDS- acetaminophen 320 mg, dextromethorphan hbr 5 mg, guaifenesin 100 mg suspension

Multi-Symptom Cold and Flu-Kids by

Drug Labeling and Warnings

Multi-Symptom Cold and Flu-Kids by is a Otc medication manufactured, distributed, or labeled by Genexa Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 mL)

Acetaminophen 320 mg

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

PURPOSE

Purposes

Pain Reliever/Fever Reducer

Cough suppressant

Expectorant

INDICATIONS & USAGE

Uses

temporarily relieves:

cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

the intensity of coughing

the impulse to cough to help your child get to sleep

minor aches and pains associated with:

the common cold fever sore throat

headache body pain

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of

bothersome mucus and make coughs more productive

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

more than 5 doses in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening

blisters

rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping

the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or

pharmacist before giving this product.

Ask a doctor before use if the child has

Liver disease

cough that occurs with too much phlegm (mucus)

persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm

(mucus) unless directed by a doctor.

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin

When using this product do not use more than directed

Stop use and ask a doctor if

pain gets worse or lasts more than 5 days

fever gets worse or lasts more than 3 days

new symptoms occur

redness or swelling is present

cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or

persistent headache.

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away

(1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

this product does not contain directions or complete warnings for adult use

do not give more than directed (see Overdose warning)

SHAKE WELL BEFORE USING

find right dose on chart below

for accurate dosing, use measuring cup provided.

Do not use with any other dosing device.

give dose every 4 hours while symptoms last

do not give more than 5 times in 24 hours

• children 6 to under 12 years: 10 mL every 4 hours
• children 4 to under 6 years: 7.5 mL every 4 hours
• children under 4 years: do not use

STORAGE AND HANDLING

Other information

store between 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

organic agave syrup, organic blueberry flavor, natural citrus extract, natural flavor, purified water

QUESTIONS

Questions?

1-855-436-3921

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SHAKE WELL before each use.

Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.

Distributed by: Genexa Inc., Atlanta, GA 30324

genexa.com | U.S. Patent No. 11,617,795

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Made in the USA with globally sourced ingredients

NDC: 69676-0087-9

PRINCIPAL DISPLAY PANEL

Genexa®

MEDICINE MADE CLEAN

Ages 4+

Kids' Multi-Symptom Cold & Flu

Acetaminophen 320 mg - Pain Reliever/Fever Reducer

Dextromethorphan HBr 5mg - Cough Suppressant

Guaifenesin 100 mg - Expectorant

Cough

Mucus

Chest Congestion

Sore Throat

Fever

Body Pain

Medicine made clean

Same effective active ingredients, but no artificial fillers.

Organic Blueberry Flavor

4 FL OZ (118 mL) Liquid

Dosing cup included

INGREDIENTS AND APPEARANCE

MULTI-SYMPTOM COLD AND FLU-KIDS 
acetaminophen 320 mg, dextromethorphan hbr 5 mg, guaifenesin 100 mg suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0087
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 10 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	320 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
CITRUS FRUIT (UNII: XDK00Z8012)
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	brown (Gold)	Score
Shape		Size
Flavor	BLUEBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0087-9	1 in 1 CARTON	08/15/2023
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	08/15/2023

Labeler - Genexa Inc. (079751024)